NEWS

Results of new validation study show agreement with previous assay performance reported in JAMA publication

June 3, 2011 - WOBURN, MA - Nuvera Biosciences, a molecular diagnostics company that develops gene-based diagnostic assays for personalized medicine in cancer, announced the results of a blinded validation study on its breast cancer assay for taxane chemotherapy response. The study is being presented at the ASCO Annual Meeting on June 4 in Chicago (McCormick Place Hall B1, 2-6pm; J Clin Oncol 29: 2011; suppl; abstr 1030). The study authors include investigators from University of Texas M.D. Anderson Cancer Center; Institut Gustave-Roussy, France ; Medical University of Graz, Austria; Institute of Oncology, University of Ljubljana, Slovenia; and Georgetown Lombardi Comprehensive Cancer Center.

The results of this blinded study corroborate the findings of a separate multicenter validation study of the same assay recently published in the May 11 issue of JAMA on test predictions from an independent cohort of 198 breast cancer patients (Hatzis et al., JAMA. 2011 May 11; 305(18):1873-81).

The treatment a patient receives at diagnosis of breast cancer offers the greatest chance for cure. In current clinical practice, there are several therapy choices offered as standard-of-care as well as potential clinical trials with novel targeted agents. The prediction of which patients may be cured by a standard chemotherapy regimen versus those who might benefit from additional or different therapies continues to be a challenge.

In the multi-site study presented at ASCO, eligible patients received adjuvant chemotherapy with sequential anthracyline and either docetaxel or paclitaxel and had at least 3 years of follow-up. The study's primary endpoints were distant relapse-free survival (DRFS) and absolute risk reduction (ARR) at 3 years of follow up. Tumor samples were sent to M.D. Anderson for gene expression profiling, and blinded genomic predictions from the assay and clinical information from study sites were matched and analyzed at Georgetown University.

In 101 patients analyzed, treatment-sensitive patients (39%) had a 3-yr-DRFS of 90% (95% confidence interval 80-99), and absolute risk reduction (ARR) of 17% (95% confidence interval 2-30) compared to treatment-insensitive patients. In contrast, patients predicted to be sensitive by three other genomic predictors showed a significantly lower DRFS, and a negative ARR (indicating an increased relapse risk). The authors conclude that in interim analysis, assay prediction of treatment sensitivity was associated with excellent and significantly improved 3-yr-DRFS following adjuvant taxane-chemotherapy or combined chemo- and endocrine therapy.

"We are excited that the results from this independently evaluated blinded study agree well with our previous validation studies of the assay," says Christos Hatzis, Ph.D., founder and VP, Technology of Nuvera Biosciences, a study co-author. "We are looking forward to making this chemotherapy predictor available as a clinically meaningful test to guide therapy selection in newly diagnosed women with invasive breast cancer," he adds.
In the study reported previously in JAMA, of the 198 patient samples tested, those predicted as treatment-sensitive (28%) had a 3-yr-DRFS of 92 percent, an ARR of18 percent, and the responsive patients had a five-fold reduction of risk of distant relapse.

Nuvera plans to continue the development of its breast cancer assays for chemotherapy and endocrine therapy response in a CLIA-certified laboratory and to work towards meeting regulatory requirements for launch as a commercial product offering.

About Nuvera Biosciences, Inc.: Nuvera Biosciences is focused on developing novel molecular diagnostics that will help achieve significantly better treatment selection and high- quality patient management in cancer. Using clinical studies conducted with leading cancer institutions worldwide, high-quality tissue access, and state-of-the-art bioinformatics technology, the Company is building a portfolio of diagnostic tests directed at making personalized medicine a near-term reality. For additional details on Nuvera and its molecular diagnostics programs, please visit www.nuverabio.com or send an email to info@nuverabio.com.